“Consumers have a right to be assured that the devices and products used during their surgeries are safe and effective,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP.
Port Washington, New York (PRWEB) May 16, 2014
Parker Waichman LLP, a national law firm long dedicated to protecting the rights of victims injured by defective medical devices, reports that device maker, Medtronic Inc., announced plans to record a charge of between $120 and $140 million to resolve hundreds of lawsuits brought over its InFuse bone growth product, according to a May 6, 2014 report by the Minneapolis/St. Paul Business Journal.
Medtronic also agreed to pay $22 million to settle about 950 lawsuits, admitting no wrongdoing or liability. The device maker previously settled a shareholder lawsuit over InFuse for $85 million in 2012, also admitting no wrongdoing, the Minneapolis/St. Paul Business Journal report indicated. The new charge will be recorded in Medtronic’s fourth-quarter results and will involve 1,200 claims that have been filed, as well as another 2,600 claims it estimates will be filed, according to the Minneapolis/St. Paul Business Journal.
In 2011, a number of spine specialists accused Medtronic of overstating InFuse’s benefits and of interfering with what were meant to be independent studies. Following the accusations, Medtronic commissioned an external study of InFuse, the Minneapolis/St. Paul Business Journal report indicated.
Medtronic approached Yale University researchers following release of The Spine Journal issue that was devoted to InFuse. Published on June 18, 2013, in the medical journal Annals of Internal Medicine, the two studies offered several key findings, namely that there is no difference between using InFuse and a traditional bone graft; that the initial Medtronic InFuse research was biased; and that there is a small, increased risk of developing cancer or, in men, retrograde ejaculation, a cause of male infertility.
The $120-$140 million involves a special charge to create settlement costs against results of its just completed fiscal fourth quarter, according to a May 7, 2014 The Star Tribune report. Those bringing lawsuits allege that InFuse led to injuries after being used in off-label, unapproved ways. InFuse received U.S. Food and Drug Administration (FDA) approval in 2002 for specific purposes. Many claims brought against Medtronic over InFuse allege injuries when the product is used for purposes for which the device had not received FDA approval.
The U.S. Senate Finance Committee also discovered issues with most of the initial Medtronic-supported InFuse research that was used to promote the bone growth product, according to an October 25, 2012 Bloomberg Businessweek report. The article’s allegations include that physicians and researchers who wrote at least 11 medical journal reports about InFuse were paid some $210 million in royalties and consulting fees. In fact, Senate investigators also charged that Medtronic deliberately manipulated studies to mitigate any adverse reactions to InFuse side effects, and to promote the product off-label use.
“Consumers have a right to be assured that the devices and products used during their surgeries are safe and effective,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “Given all of the recent findings associated with InFuse, one has to wonder whether its benefits actually outweigh its dangers.”
Parker Waichman LLP continues to offer free lawsuit consultations to victims of Medtronic InFuse injuries. If you or a loved one experienced complications following Medtronic InFuse surgery please visit the firm's Medtronic InFuse page. Free case evaluations are also available by calling 1-800-LAW-INFO.